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Viral and Host Factors in the Transmission and Pathogenesis of HIV

This study is currently recruiting participants.
Verified February 2013 by Rockefeller University
Sponsor:
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00219947
First received: September 20, 2005
Last updated: February 28, 2013
Last verified: February 2013
History of Changes

September 20, 2005
February 28, 2013
July 2000
July 2013   (final data collection date for primary outcome measure)
Participants are tested for HIV-1 RNA levels, the presence of antibodies to HIV antigens, and T cell subsets [ Time Frame: first visit ] [ Designated as safety issue: No ]
Participants are tested for HIV-1 RNA levels, the presence of antibodies to HIV antigens, and T cell subsets
Complete list of historical versions of study NCT00219947 on ClinicalTrials.gov Archive Site
Data will be used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment [ Time Frame: first visit ] [ Designated as safety issue: No ]
Data will be used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment
Not Provided
Not Provided
 
Viral and Host Factors in the Transmission and Pathogenesis of HIV
Viral and Host Factors in the Transmission and Pathogenesis of HIV

To study the collection of blood from individuals known to be at high risk for HIV-infection or who have been recently infected with HIV.

The data collected are used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment Guidelines.

This phlebotomy protocol permits the collection of blood from individuals known to be at high risk for HIV-infection or who have been recently infected with HIV.

Participants will have from 10 to 60 ml (approximately 1 to 4 tablespoons) of blood drawn for one or all of the following tests:

  • T cell subset enumeration
  • Serologic reactivity with HIV antigens
  • Viral load assays by bDNA, PCR, or RT-PCR
  • Routine Laboratory assessments (chemistries, liver function tests, hepatitis serology, RPR)
  • HIV-1 Resistance Testing

These data are used for diagnostic, prognostic and management decisions as outlined by current HIV-1 Treatment Guidelines
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood
Non-Probability Sample

Subjects are either referred by primary health care providers, self-referred, or may be seeking enrollment in other ADARC clinical trials in the NYC area.
HIV Infections
Procedure: blood draw

Participants will have from 10 to 60 ml blood drawn for one or all of the following tests:

  • T cell subset enumeration
  • Serologic reactivity with HIV antigens
  • Viral load assays by bDNA, PCR, or RT-PCR
  • Routine Laboratory assessments (chemistries, liver function tests, hepatitis serology, RPR)
  • HIV-1 Resistance Testing
  • high risk
    individuals known to be or at high risk for HIV-infection
    Intervention: Procedure: blood draw
  • diagnosed
    diagnosed with HIV infection
    Intervention: Procedure: blood draw
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Subjects of the study include HIV-1 infected and high risk individuals.
Both
18 Years and older
No
Contact: Don Garmon 212-327-7290 dgarmon@adarc.org
United States
 
NCT00219947
MMA-448
Yes
Rockefeller University
Rockefeller University
Not Provided
Principal Investigator: Martin M Markowitz, MD Rockefeller University
Rockefeller University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP